Limited access suturing devices, system, and methods

Abstract

Medical suturing devices, systems, and methods will be useful for endoscopic (with or without access ports) or other surgeries in which access is limited, including ear, nose, and throat procedures. Articulation motions may be transferred from a handle to needle grasping jaws using an axial movement of a shaft that has axial stiffness (such as being stiff in compression) and lateral flexibility or an axial movement of a cable. An extension body (within which the shaft or cable moves) between the handle and jaws can be pre-bent or custom bent by the user. Portions of the devices may be disposable, replaceable, and/or reusable. A spring adjacent the clamp may open the clamp or impose a gripping force.

What is claimed is: 
     
       1. A suturing method of suturing a tissue of a patient, said method comprising:
 grasping a proximal portion of a suturing needle with a first clamp of a suturing device, the suturing device having a body with a proximal end and a distal end, wherein the first clamp is supported by an elongate extension of the body, the extension extending along an axis toward the distal end and having a bend in the axis, wherein grasping of the needle with the first clamp is effected by axially moving an associated first shaft along the axis through the bend within the extension, the first shaft having axial stiffness sufficient to compressively transmit axial movement and being laterally flexible to accommodate the bend within the extension; 
 inserting a distal portion of the needle through the tissue by moving the body supporting the extension so that the needle moves in correlation with the body; 
 grasping the distal portion of the needle with a second clamp of the suturing device, wherein the second clamp is supported by the elongate extension of the body, wherein grasping of the needle with the second clamp is effected by axially moving an associated second shaft along the axis through the bend within the extension, the second shaft having axial stiffness sufficient to compressively transmit axial movement and being laterally flexible to accommodate the bend within the extension; 
 releasing the proximal portion of the needle from the first clamp; and 
 pulling the proximal portion of the needle through the tissue by moving the body while the second clamp holds the distal portion of the needle. 
 
     
     
       2. The suturing method of  claim 1 , wherein the needle is rigidly affixed relative the body of the suturing device when grasped by each of the first and second clamps so as to allow a distal end of the needle to be inserted through the tissue when grasped by the first clamp and to be pulled free from the tissue when grasped by the second clamp by moving the needle in rigid correlation with the body grasped by a single hand of a surgeon. 
     
     
       3. The suturing method of  claim 2 , wherein grasping and releasing of the needle with the first and second clamps is effected by alternating movement of a linkage coupled to each of the first and second shafts, the alternating movement of the linkage being effected by articulation of a proximal handle of the body disposed near the proximal end so as to allow one or more fingers of the single hand to effect alternating grasping of the needle with the first and second clamps while grasping the proximal handle with the single hand. 
     
     
       4. The suturing method of  claim 1 , wherein grasping and releasing of the needle with the first and second clamps is effected by alternating movement of a linkage coupled to each of the first and second shafts. 
     
     
       5. The suturing method of  claim 4 , wherein the alternating movement of the linkage is effected by articulating a proximal handle near the proximal end of the body. 
     
     
       6. The suturing method of  claim 1 , further comprising:
 selecting the extension, wherein the extension is pre-bent for a particular therapy or patient. 
 
     
     
       7. The suturing method of  claim 1 , further comprising:
 imposing the bend on the extension, the extension being plastically deformable along the axis to allow imposition of the bend prior to suturing and sufficiently stiff to support the first and second clamps during suturing. 
 
     
     
       8. The suturing method of  claim 1 , further comprising:
 manually rotating the extension relative the body so as to alter an orientation of the bend relative to the body and/or an orientation of the first and second clamps relative to the extension. 
 
     
     
       9. The suturing method of  claim 1 , further comprising:
 manually twisting the extension about the axis prior to suturing so as to vary an angle of the needle relative to the axis of the body. 
 
     
     
       10. The suturing method of  claim 1 , wherein each of the first and second clamps comprises a pair of jaws and wherein grasping of the needle with each of the first and second clamps comprises axially moving the respective shaft in a first axial direction thereby causing sliding movement of an associated wedge along a slide surface of the respective pair of jaws so as to close the pair of jaws of the respective clamp. 
     
     
       11. The suturing method of  claim 10 , wherein releasing of the needle with the first clamp comprises axially moving the first shaft in a second axial direction thereby causing sliding movement of the associated wedge along the slide surface of the pair of jaws of the first clamp so as to open the first clamp and release the needle. 
     
     
       12. The suturing method of  claim 1 , further comprising:
 inserting the distal end of the device including the extension having the bend, through a trocar within a minimally invasive aperture. 
 
     
     
       13. The suturing method of  claim 1 , wherein the first and second clamps, the first and second shafts and the extension together comprise a clamp unit releasably attached to a drive unit of the device, the method further comprising:
 selecting the clamp unit from a plurality of alternative releasably attachable clamp units according to a particular therapy or patient, wherein the plurality of clamp units, when alternatively mounted to the drive unit, define different bend angles, extension lengths, clamping forces, needle sizes, or clamp types. 
 
     
     
       14. The suturing method of  claim 1 , wherein each of the first and second shafts comprise a series of spherical compression elements. 
     
     
       15. The method of  claim 1 , wherein each of the first and second shafts comprises a series of shaft elements having joints therebetween and wherein transmitting axial movement of each of the first and second shaft comprises transmitting axial movement through the series of elements as a compressive load. 
     
     
       16. The suturing method of  claim 1 , wherein grasping and releasing of the needle with the first and second clamps is coordinated by cycling of a linkage coupled to each of the first and second shafts, cycling of the linkage being effected by articulating a proximal handle of the device. 
     
     
       17. The suturing method of  claim 1 , wherein grasping and releasing of the needle is coordinated such that the needle is released from the first clamp after grasping of the needle with the second clamp. 
     
     
       18. The suturing method of  claim 1 , wherein each of the first and second clamps grasp the needle at a fixed location relative to the body such that the clamps inhibit movement of the needle relative to the body while support of the needle is alternated between first and second clamps. 
     
     
       19. The suturing method of  claim 18 , wherein the fixed location comprises an extended grasping position, the method further comprising:
 after releasing the proximal portion of the needle, moving the first clamp axially away from the needle from the extended grasping position to a retracted position closer to the body so that the proximal portion of the needle is axially separated from the clamp along the axis, wherein the first clamp moves axially using axial movement of the first shaft relative to the body. 
 
     
     
       20. The suturing method of  claim 19 , wherein grasping the needle with each of the first and second clamps comprises advancing the respective clamp along the respective axial towards the needle using axial movement of the respective shaft relative to the body. 
     
     
       21. The suturing method of  claim 20 , wherein grasping the needle with each clamp comprises advancing the respective clamp distally slightly beyond the fixed location at which the respective clamp supports the needle during suturing so as to inhibit movement of the needle relative to the body while support of the needle is alternated between first and second clamps. 
     
     
       22. A suturing method of suturing a tissue of a patient, said method comprising:
 grasping a proximal portion of a suturing needle with a first clamp of a suturing device, the suturing device having a body with a proximal end and a distal end, wherein the first clamp is supported by an elongate extension of the body, the extension extending along an axis toward the distal end and having a bend in the axis, wherein grasping of the needle with the first clamp is effected by axially moving an associated first shaft along the axis through the bend within the extension, the first shaft having axial stiffness sufficient to transmit axial movement and being laterally flexible to accommodate the bend within the extension; 
 inserting a distal portion of the needle through the tissue by moving the body supporting the extension so that the needle moves in rigid correlation with the body; 
 grasping the distal portion of the needle with a second clamp of the suturing device, wherein the second clamp is supported by the elongate extension of the body, wherein grasping of the needle with the second clamp is effected by axially moving an associated second shaft along the axis through the bend within the extension, the second shaft having axial stiffness sufficient to transmit axial movement and being laterally flexible to accommodate the bend within the extension, wherein the extension is sufficiently stiff to alternatingly support the needle with the first and second clamps and maintain the bend during suturing; 
 releasing the proximal portion of the needle from the first clamp; and 
 pulling the proximal portion of the needle through the tissue while the second clamp holds the distal portion of the needle by moving the body supporting the extension so that the needle moves in rigid correlation with the body. 
 
     
     
       23. The method of  claim 22 , further comprising:
 manually imposing the bend in the extension, the extension being plastically deformable along the axis to allow bending of the extension and sufficiently stiff to alternatingly support the needle with the first and second clamps during suturing after imposition of the bend. 
 
     
     
       24. The method of  claim 22 , further comprising:
 selecting the extension having the bend, wherein the extension is pre-bent for a particular therapy or patient. 
 
     
     
       25. The method of  claim 22 , wherein each of the first and second shafts comprises a series of shaft elements having joints therebetween and wherein transmitting axial movement of each of the first and second shaft comprises transmitting axial movement through the series of elements as a compressive load. 
     
     
       26. The method of  claim 25 , wherein the series of shaft element comprise a series of spherical bodies and the joints therebetween comprise indentations in the spherical bodies to slidingly receive an adjacent spherical body. 
     
     
       27. The method of  claim 25 , wherein the joints between adjacent shaft elements of the series of shaft elements comprises a ball-and-socket joints so as to transmit compressive load and accommodate lateral movement of the respective shaft during axial movement through the bend of the extension.